Preferred Label : Mutual Recognition Procedure;
NCIt synonyms : MRP;
NCIt related terms : mutual recognition procedure (MRP);
NCIt definition : A European authorization process in which a marketing authorization holder for a product
that is already authorized in at least one Member State, known as the Reference Member
State, seeks to obtain marketing authorization for the same product in at least one
other Member State, known as the Concerned Member State(s).;
Alternative definition : CDISC-GLOSS: The EU procedure to be used when a product is already authorized in at
least one Member State and the Marketing Authorization Holder wishes to obtain a Marketing
Authorization (MA) for the same product in at least one other Member State. The Member
State that has already authorized the product is known as the Reference Member State
(RMS). The RMS submits their evaluation of the product to other Member State/s, these
are known as Concerned Member State/s (CMS). If the applicant is successful, the CMS
will then issue a MA for that product permitting the marketing of that product in
their country. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html]
See also Reference Member State (RMS) and Concerned Member State (CMS).;
NCI Metathesaurus CUI : CL935708;
Origin ID : C156635;
UMLS CUI : C4723823;
False automatic mappings
- Semantic type(s)
- concept_is_in_subset
